regulatory
confidence high
sentiment positive
materiality 0.75
NeuroOne receives FDA 510(k) clearance for OneRF Trigeminal Nerve Ablation System
NEUROONE MEDICAL TECHNOLOGIES Corp
- FDA 510(k) clearance granted for OneRF Trigeminal Nerve Ablation System.
- System used for radiofrequency lesions to treat pain and functional neurosurgery.
- Clearance announced on August 18, 2025.
item 8.01